Description and Brand Names

US Brand Name

Metvixia

Descriptions

Methyl aminolevulinate is used with photodynamic therapy (light treatment) to treat actinic keratosis (AK) on the face and scalp. Actinic keratoses are skin lesions or growths in areas where the skin has been exposed to the sun. AK normally occurs in older patients with light-colored skin. This medicine is only used for AK skin lesions that are thin and light in color.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Cream

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of methyl aminolevulinate in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of methyl aminolevulinate in the elderly.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

photosensitivity (skin sensitive to sunlight), history of—Should not be used in patients with these conditions.

Bleeding problems or

Skin cancer or other skin lesions, history of—Use with caution. May cause side effects to become worse.

Proper Use

Methyl aminolevulinate will be applied to your skin in a clinic or doctor's office. You will receive two treatments with this medicine spaced 1 week apart.

Methyl aminolevulinate is for use on the skin only. Do not get it in your eyes, nose, or mouth. If it does get on these areas, tell your doctor right away.

Precautions

It is very important that your doctor check your progress three months after the treatment. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

This medicine causes the treated areas of your skin to be more sensitive to light. Avoid exposure to sunlight or bright indoor light for 3 hours after the medicine is applied to your skin. This includes medical examination lights, operating room lights, tanning beds, or any lights that are close to you. You should also avoid exposure to sunlight or bright indoor light on the treated skin for 2 days after the light treatment (photodynamic therapy). Cover the treated areas of your skin. If you must go out during daylight hours, wear a protective hat or clothing. Check with your doctor if you have questions about this.

Avoid cold temperatures for 3 hours after the medicine is applied to your skin. Wear warm clothing and cover the treated area if you are in cold places.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Breakdown of the skin

irritation and redness of the skin

scabbing

swelling of the eyelid

swelling of the skin

Less common

Discharge at the site of application

sores on the skin that do not heal

Incidence not known

Blistering, burning, crusting, dryness, or flaking of the skin

blurred vision or other change in vision

eye redness, irritation, or pain

hives or welts

itching, scaling, or severe redness of the skin

persistent non-healing sore

pink growth on the skin

reddish patch or irritated area on the skin

seeing flashes or sparks of light

seeing floating spots before the eyes, or a veil or curtain appearing across part of the vision

shiny bump on the skin

skin rash, encrusted, scaly and oozing

white, yellow, or waxy scar-like area on the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Darkening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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